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After spending several years touring the country as a stand up comedian, Ed Brayton tired of explaining his jokes to small groups of dazed illiterates and turned to writing as the most common outlet for the voices in his head. He has appeared on the Rachel Maddow Show and the Thom Hartmann Show, and is almost certain that he is the only person ever to make fun of Chuck Norris on C-SPAN.

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Fed. Judge Overturns Obama on Morning After Pill

A federal judge has overruled an Obama administration rule that forbid the sale of emergency contraception — the morning-after pill — to girls under 17 without a prescription. Judge Edward Korman, a Reagan appointee, said the rule was the result of “a strong showing of bad faith and improper political influence.” You can read the full ruling here.

The complaint asserted that the FDA’s denial of the Citizen Petition, which it considered along with a number of proposals regarding over-the-counter access to emergency contraception submitted by Plan B’s sponsor, was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making. In a prior opinion, I concluded that the plaintiffs were right.

The commissioner of the FDA had recommended that Plan B contraception be made available without a prescription to women or all ages, saying “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.” But Secretary of Health and Human Services Kathleen Sebelius disagreed with that decision and overruled it and President Obama supported her decision. Press Secretary Jay Carney repeated after this ruling that President Obama still supported the decision not to make it available to those under 17. The judge noted that and showed why it was wrong:

The President endorsed this decision, explaining that “the reason [Secretary Sebelius] made this decision was she could not be confident that a 10-year-old or an 11-year-old go into a drugstore, should be able—alongside bubble gum or batteries—be able to buy a medication that potentially, if not used properly, could end up having an adverse effect.” The reader will observe that Secretary Sebelius did not say that, “if not used properly,” levonorgestrel-based emergency contraception could have an “adverse effect” on the youngest girls of reproductive age, nor did she include within that group girls as young as 10. Indeed, the drug is currently available to the youngest girls of reproductive age with a prescription.

This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed. Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.

I can’t wait to see how the wingnuts blame Obama for this. And I really wonder whether Obama will appeal the ruling or let it stand. If he appeals it, there’s a good chance it would get overturned. If he doesn’t, the ruling stands and this form of contraception would be more widely available.

Comments

This is a tricky one…we don’t let children buy cigarettes or beer or even cold medications that have pseudoephedrine in them (in my state at least).

Is a 12-year-old mature enough to handle this? A pregnant 12-year-old? That’s gotta be a case-by-case thing.

But if a kid really needs help — what are the options? Darn few to none. I don’t think there’s a “good” decision. I do think Obama may have looked at his daughters and led with his heart and not his head — but that’s pure fantasy supposition on my part.

I suspect more than a few pharmacies will refuse to carry the drug. There are no rules that say a pharmacy has to carry every drug that’s available for prescription. This ruling, in my opinion, would narrow someone’s choices even further. Perhaps to the point of the drug effectively being unavailable to anyone who really needs it.

I would also suspect the thing will be hella expensive.

I agree that the ruling would be overturned, because the courts have traditionally not interfered with the regulatory decision-making process.

The Faux News people’s heads were exploding over this Sunday morning. Somehow, it’s Obama’s fault that the judge overturned the rule…yeah…

There are no rules that say a pharmacy has to carry every drug that’s available for prescription. This ruling, in my opinion, would narrow someone’s choices even further. Perhaps to the point of the drug effectively being unavailable to anyone who really needs it.

I would also suspect the thing will be hella expensive.

Actually it is going to be available without a prescription, although pharmacies aren’t required to carry those either. At about $30 it probably will be behind the counter to prevent pilferage, but it isn’t likely to be taken if not needed for the very same reason.

Let me preface this by saying that I am fully and completely supportive of women’s reproductive rights.

I’m sorry, but I don’t believe that “safer than ibuprofen” has been proven.

Plan B or Plan B One-Step is considered safe for most women. You should not take it if you are pregnant; at this time, there is limited data on the safety of taking Plan B or Plan B One-Step while pregnant.

Plan B or Plan B One-Step causes less nausea and vomiting than ECPs that contain both estrogen and progestin. And, you may be able to reduce any nausea or vomiting by taking the pill on a full stomach. Eating small, frequent meals over 24 hours may also help.

With Plan B or Plan B One-Step, you may also have some unexpected bleeding. It should go away by the time of your next period. However, it is possible that Plan B or Plan B One-Step may cause your next period to be heavier or lighter than usual. It may also come earlier or later than is normal for you. If you don’t get your period within three weeks, get a pregnancy test to make sure you’re not pregnant.

Doesn’t sound like ibuprofen to me…and frankly, the admonition against using it while pregnant? What 12-year-old is going to use it as a “morning after” pill? And how many of them are going to miss their periods, and take one of these thinking that she can make the whole thing go away?

Sorry. Not convinced it’s all that safe — or that children would know how to use it correctly (or care). It’s not meant as an abortifacient, but that’s how it’s going to be used in that population. And that’s a problem.

Actually, it does sound like ibuprofen. And just about every other medication that you can buy over the counter. The exact side effects which may occur might be different somewhat, but I see no essential difference between Plan B and other medications.

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Sorry. Not convinced it’s all that safe….

The judge was convinced. Presumably after hearing testimony that included the reports by the FDA.

Seemed that before the politics got involved that the FDA felt it was save, too, at least safe enough to allow to be sold over the counter.

None of this is to say I know which drug is safer, I don’t, but a mere listing of all the side effects something could have however rarely is not an adequate assessment of its safety and if we stuck to drugs that never had side effects there pretty much wouldn’t be any.

Chiroptera…conveniently ignored the second half of my objection, I see.

Safe when used as directed for the purpose for which it’s intended. Do we have data on its safety when used inappropriately? Why no…it says so right there…

“there is limited data on the safety of taking Plan B or Plan B One-Step while pregnant.”

Still not convinced. Frankly, more concerned than before. What procedures are going to be put into place to ensure the product is used as directed? That’s the number 1, number 2, number 3, and number 100 issue…and every other number in between.

And I’ve dealt with the FDA and their decisions. Let me just say that my admiration for the tough job they do is tempered by my concern over the sometimes bizarrely illogical, anti-data-driven decisions they’ve made. There are drugs on the market (cough-Cymbalta-cough) that should not be taken by humans — or any other animal.

What steps are put in place to make sure that ANY over-the-counter drug is used as directed? An 11-year old can buy Tylenol and destroy her liver by not taking it as directed. Why are you singling out Plan B as requiring special precautions?

Do you have a comparison of the risks of Plan B with other over the counter medication or information on how common various effects are? As I’ve said merely listing potential side effects is not an adequate risk assessment and you certainly can’t make a comparative judgement of two drugs by looking at the effects of one and not the other.

Then you obviously have never looked at possible side effects of ibuprofen.

Here’s a partial listing:

Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Blistering, peeling, or red skin rash.
Bloody or black, tarry stools.
Change in how much or how often you urinate.
Chest pain, shortness of breath, or coughing up blood.
Dark-colored urine or pale stools.
Fever, neck pain, or stiff neck.
Numbness or weakness in your arm or leg, or on one side of your body.
Pain in your lower leg (calf).
Problems with vision, speech, or walking.
Rapid weight gain.
Redness or swelling of the body area where you have pain.
Severe stomach pain.
Shortness of breath, cold sweat, and bluish-colored skin.
Skin rash or blisters with fever.
Sudden or severe headache.
Swelling in your hands, ankles, or feet.
Trouble seeing, change in how you see colors.
Unusual bleeding, bruising, or weakness.
Vomiting blood or something that looks like coffee grounds.
Yellowing of your skin or the whites of your eyes.
Constipation, diarrhea, or upset stomach.
Dizziness or headache.
Mild nausea, vomiting, gas, stomach pain, or heartburn.
.

Tylenol can cause severe liver damage in young people (also with alcohol). Yet both these drugs are considered “safe”.

Last I checked, there was no good evidence that Plan B is an abortifacient. On the contrary, I recall reading several papers that indicated that there was no loss of pregnancy when Plan B was given to pregnant animals. Nor, might I add, does it block implantation of an already fertilized ovum.

No Kevin, I can’t demand you do anything. I can ask though. I’m sorry that it makes you angry that I’m reading you as having ulterior motives, but you would read me the same way if the roles were reversed. If you refuse to clearly state why you think restricting this is a better option than pregancy, and when you won’t acknowledge very reasonable points by others about the safety and efficacy of all other already over the counter drugs, what would you have me think? Really.

It’s very straightforward, and very reasonable, to ask “OK. But the same goes for all other drugs, yet you’re not proposing we restrict aspirin, for example, based on how it will be used. Why are you treating Plan B differently?” Totally reasonable. Also reasonable to be very suspicious of your motives if you refuse to acknowledge the question. It’s not me out in left field.

Just because other OTC products have listed side effects (and yes, I can’t take many of them precisely because of their side effects) that does not absolve Plan B from its potential harmful effects — especially given the likelihood that it will not be used as intended in this patient population.

Again, and for the last time: My concern is about this commercial product. Not some other commercial product. Comparing side effects against some other product in a completely different product category is worthless at best. And I’m surprised anyone would think that would be an appropriate way to judge the safety and efficacy of any pharmaceutical.

The risk-benefit of the product has to be considered not against every product on the marketplace, but in the marketplace for which it exists. What is under discussion is teen-aged girls using it as indicated within 24 to 72 hours of unprotected sex. And, in this case, the marketplace for which it will likely be used inappropriately — a teen-aged girl who had unprotected sex some days before and who just missed her period.

Now, in the interim between my last post and this one (sorry I took so much time Josh, to actually do the research), I went on the FDA web site and read the Medical Officer’s report on this product.

I will say that in general the post-marketing surveillance has generally found no problems that would signal this product can’t be offered OTC for adults. There’s a fairly robust database involving several million uses worldwide. I think OTC use in adults is safe enough, when used as directed.

However, there’s still that nagging concern about younger women especially when taken for an unlabeled use. For me, it’s all about the safety in a population that doesn’t appear to have been adequately studied … at least not according to the report of the Medical Officer, which doesn’t address the age of the users at all. Don’t know if they collected that data and didn’t report it, or didn’t report it because they don’t have it.

Frankly, the silence about this issue is troublesome. And though I don’t know what went into the Administration’s decision, if I had to point a finger at a reason for their actions, that would be the most logical one to me. Plus the emotional “my daughter” reasons which I previously stated (which aren’t good reasons FWIW, but that was a supposition on my part anyway).

BTW, and just so this loop is closed. Plan B is NOT meant as an abortifacient. In fact, the data from the Medical Officer’s report suggests that it’s ineffective if it’s attempted to be used for that purpose. But at least there’s no signal for teratogenicity, or for an increased risk of ectopic pregnancies. I just won’t work.

Just because other OTC products have listed side effects (and yes, I can’t take many of them precisely because of their side effects) that does not absolve Plan B from its potential harmful effects — especially given the likelihood that it will not be used as intended in this patient population.

And the sudden concern for the hypothetical abuse of this one pharmaceutical, compared to the many others which we as a society have determined to have acceptable risks, is just a coincidence?

The usual complaint about the FDA is that they’re excessively cautious and refuse to allow marketing of drugs without unreasonable amounts of research into safety. And yet this one which is, per the FDA report, one of the safest possible drugs, suddenly raises your suspicions (without, I note, actually reading the FDA paper on its safety) for reasons that are not in the least clear.

When you’re complaining that the FDA, the American College of Obstetricians and Gynecologists, and half a dozen other high-powered experts in the field are missing an unspecified something that only applies to this one chemical — well, then, I’ll match your suspicions regarding the drug with mine regarding your agenda.

And, no, it’s not tu quoque to place risks in order and propose that the larger ones receive our concern before the lesser ones.

It hasn’t been adequately studied in younger women. You can’t extrapolate from one age group to another.

And the FDA would disagree with you 100% about the assignment of risks. I’m quite sure the safety of ibuprofen or acetaminophen in relation to the safety of Plan B never came up in any discussion. Because it’s not germane.

Again, I’ve worked with the FDA. Seen them in action. Understand the process. Participated in the process. It is inappropriate at best — bizarrely illogical at worst — to consider the safety of a product not in the same therapeutic category against the safety of another product in a completely different category.

Please stop using arguments the FDA itself would reject out of hand as inappropriate to their decision-making process. OK?

Kevin, #18:Chiroptera…conveniently ignored the second half of my objection, I see.

Safe when used as directed for the purpose for which it’s intended. Do we have data on its safety when used inappropriately? Why no…it says so right there…

Well, I was going to mention minors drinking Nyquill to get drunk, but I guess I thought my point had already been made. Perhaps not clearly.

My point has already been made be another commentor. Every single objection you bring up can be levelled against many, perhaps most, other medications that are already available over the coounter, even to 10 year olds. Like others, I find it significant that suddenly these objections become serious when they deal with an issue that has important ramifications in regard to the politically charged issue of women’s control over their bodies and their reproduction. Maybe that’s just a coincidence, but surely you can understand, in the context of contemporary US politics, why many commentors will have their doubts.

Chioptera: And again, that is the tu quoque logical fallacy writ large. That dog won’t hunt, as they say down in Foggy Bottom.

The FDA would not use that type of comparison. The Administration did not use that type of comparison. It’s completely and totally inappropriate to say “well, this drug causes boils, so as long as that drug only causes superating pustules, it’s OK.”

2. Is use of Plan B in younger teens safe? We don’t know. There are no reported data in this population.

3. Is it likely that Plan B is safe in younger teens? There are no data reported on the safety of Plan B, either used appropriately or inappropriately. The only appropriate answer is “we don’t know”.

4. How likely is it that Plan B is safe in older women, but not in younger? It is impossible to assign “odds”. Probably not very likely, but the younger the woman in question, the more likely there might be a signal we don’t know about. A 13-year-old is not the same as a 17-year-old. And there are no data in the younger age group. No knowledge = no knowledge. Not “well, it’s probably OK”.

5. If someone (anyone/any age) takes Plan B because they missed their period and thinks she’s pregnant, what would happen? She would probably get a belly ache which would be indistinguishable from morning sickness — which she may have because Plan B won’t terminate a pregnancy. So, she spent $30 to make herself sick and still be pregnant. There’s no signal at present — in ADULT women — for birth defects or for increased risk of ectopic pregnancies.

___

*We don’t know — or at least I haven’t found — any reports that indicate long-term problems with one or multiple uses of Plan B. However, we didn’t think DES could cause birth defects in the grandchildren of women who took it, either. We didn’t think there was a difference in safety between Vioxx and Celebrex. We didn’t think that Viagra could cause sudden blindness. “We” were wrong.

You finally give an example of unlabeled use in #32, namely a teenage girl taking it some unspecified number of days after unprotected sex AND discovering her period is late/missed. Considering that Plan B is a one time use, I can’t see how the effects would be any different than if she had taken it as intended other than the fact that it’s almost certainly too late to prevent pregnancy. The same potential side effects still apply. And it’s not an abortifacient, as you admit, so there should be no additional negative effects if she waits this long. Really, the only way I can see this drug being abused is if there is someone who is regularly sexually active and refuses to take any other precautions besides swallowing a Plan B pill after every incident of unprotected sex. I think most people would agree that a woman who takes Plan B daily, or several times a week, or even once a week is abusing this drug and using in an off-label manner that may have adverse health effects. I just don’t think this scenario is likely, especially with a 12 year old girl (your scenario) who presumably has very limited funds. No, the only additional risk to a 12 year old girl who takes it too late is that she may already be pregnant and now has to make additional decisions on whether or not to terminate the pregnancy.

Josh: You misunderstand me completely. Where have I advocated restricting OTC sale of Plan B for younger teens? I have not done so.

I am sounding what I think is an appropriate note of caution. The safety of this product — whatever its status as Rx or OTC — has not been established in this patient population. We know neither the short-term nor the long-term consequences of single or multiple uses of Plan B in younger females. And it’s just not appropriate to say “well, I’m willing to take the risk” on behalf of them.

Am I being more conservative than the FDA? Yes. It happens. Sometimes, the FDA gets it wrong. Although it is actually set up to err on the side of caution, in reality things happen and products are moved into the marketplace that don’t belong there.

Is this one of them? For adult women, at present I think the answer is pretty clear that Plan B is safe when used as directed. But we still haven’t begun to see the “DES”-type situation. The product has only been on the market since 1999. So, any children born to women who took Plan B and later got pregnant are just now starting to have children of their own. The longer things go with no signal, the happier I’ll be.

But that still doesn’t address the fact that we don’t know the safety of Plan B in the youngest population likely to use it. That worries me. I’m shocked that it doesn’t worry you.

No, I don’t. But if you’re satisfied that you’ve successfully rebutted my replies to you, I guess that’s what matters.

–

Let’s unpack this for clarity.

It was clear the first time you wrote it. If you aren’t happy with my or others’ response to it, I guess I don’t have anything else to say. I’d just repeat the exact same thing I’ve already written, and then you’d presumably repeat the exact same thing you’ve already written. At least, that’s what my internet experience has led me to expect.

Me, I think it’s an important point that this one medication that happens to be the subject of a raging political controversy should just happen to be the one medication that should be treated differently from all the other medications that have been deemed safe enough for over the counter sales.

thztds: Again, I think the likelihood of there being a different signal in younger females than in older is small, but non-zero. One-time or multiple use. There’s a lot we still don’t know about the human body.

For example, what if I were to tell you that your mom can give you schizophrenia? Impossible, you say. Yet, that’s where some research is pointing. Women exposed to influenza early in pregnancy appear to have a greater chance of having their child be diagnosed with schizophrenia.

I don’t like not knowing. And I especially don’t like not knowing and declaring it’s therefore OK to conduct an experiment that will likely involve millions of young women.

I gotta do meat space stuff now, so I won’t be replying further tonight.

But let me once again state for the record that I fully support reproductive rights for women. Just not by doing what amounts to an uncontrolled clinical trial in a vulnerable population.

Comparing side effects against some other product in a completely different product category is worthless at best. And I’m surprised anyone would think that would be an appropriate way to judge the safety and efficacy of any pharmaceutical.

Are you the one who started this debate by arguing that you were not convinced Plan B is safer than Ibuprofen and did so by listing side effects? If other people are making that comparison in more detail it is because you raised it first and with the clear implication that Plan B is somehow less safe than other OTC drugs. Faced with contradictory points you now retreat to saying the comparison which you raised is not appropriate.

Unlike others I’m not going to speculate on your motives and I’ll take your word for it that you are worried about the relative weakness of age specific evidence but if you want people to play your game you have to leave the goalposts in one place.

None of this is to say I know which drug is safer, I don’t, but a mere listing of all the side effects something could have however rarely is not an adequate assessment of its safety and if we stuck to drugs that never had side effects there pretty much wouldn’t be any.

It’s important to note that with the way FDA clinical trials work, basically if one person says during the trial, “I felt kind of dizzy after I took the medicine,” the manufacturer is obligated to put that it can cause dizziness as a side effect.

I don’t think it’s an exaggeration at all. The lawyers are completely in control of the CYA statements. It’s only a matter of time before some drug label has to say “Side effects may include: Yada, yada, yada…,Being hit by a bus,…Blah, blah, blah….

As far as I can tell, you get one pill for $40-50. So no one is going to buy a whole lot of pills. And in terms of risks, there are so many more risks with pregnancy. I mean, duh! And plan b is less risky than RU486 and abortions when you think about it

It’s important to note that with the way FDA clinical trials work, basically if one person says during the trial, “I felt kind of dizzy after I took the medicine,” the manufacturer is obligated to put that it can cause dizziness as a side effect.

That is why you do double blind, placebo controlled trials.

Sometimes on the label, they compare the side effects of the drug with the placebo.

@raven:
The thing is, the placebo can under some circumstances cause side effects.

There was a discussion recently over on Respectful Insolence, about some quack’s favoured cancer treatment, which had no rational reason for working and didn’t show much in the way of effects in the tests. The proponents were crowing about the fact that, among the subgroup of people who were diabetic, the compound under test did show statistically better results than the placebo, and this obviously meant that it actually worked, and more tests were needed as to why, etc., etc….

One of the commenters pointed out that the more likely explanation was that the actual compound did absolutely nothing, but that the glucose solution used as the placebo had statistically negative effects on the diabetics.

Making sure your placebo does nothing can be a lot more difficult than it looks.

Briefly, Plan B One-Step is a progestin (~ progesterone, a hormone produced in both non-/pregnant states) ECP. The only relevant population for Plan B One-Step is, obviously, the post-menarchal one => adult/teenager is a meaningless distinction when it comes to drug’s action/safety. And, since both dedicated progestin ECPs and OCP have been in use for decades, not only is the the safety data reported, it is actually established.

So:

2. Is use of Plan B in younger teens safe? We don’t know. There are no reported data in this population.

Drug safety profile is independent of teenage status. Only pre-/post-menarche matters.That having been said, maybe “we” don’t know, but the American Academy of Pediatrics does and recommends use. Also, it’s clearly Teva’s fault. It forgot to report to you but, in its defense, it did submit actual-use study data for females <18 to the FDA.

3. Is it likely that Plan B is safe in younger teens? There are no data reported on the safety of Plan B, either used appropriately or inappropriately. The only appropriate answer is “we don’t know”.

Are you royalty? Because if not you should make it clear that all this is just your [uninformed] opinion.

4. How likely is it that Plan B is safe in older women, but not in younger? It is impossible to assign “odds”. Probably not very likely, but the younger the woman in question, the more likely there might be a signal we don’t know about. A 13-year-old is not the same as a 17-year-old. And there are no data in the younger age group. No knowledge = no knowledge. Not “well, it’s probably OK”.

OK, last time. 13 yo or 17 yo irrelevant for drug’s safety profile. What matters is onset of ovulation/menses.

5. If someone (anyone/any age) takes Plan B because they missed their period and thinks she’s pregnant, what would happen? She would probably get a belly ache which would be indistinguishable from morning sickness — which she may have because Plan B won’t terminate a pregnancy. So, she spent $30 to make herself sick and still be pregnant. There’s no signal at present — in ADULT women — for birth defects or for increased risk of ectopic pregnancies.

Oh, and have I mentioned that being an ADULT, makes no difference to the drug’s safety profile?

*We don’t know — or at least I haven’t found — any reports that indicate long-term problems with one or multiple uses of Plan B. However, we didn’t think DES could cause birth defects in the grandchildren of women who took it, either. We didn’t think there was a difference in safety between Vioxx and Celebrex. We didn’t think that Viagra could cause sudden blindness. “We” were wrong.

You know what else we don’t know? How are you incapable of finding this basic information?

In any case, I couldn’t agree with you more. Since we were wrong on the safety profile of some drugs, we should immediately restrict the use of all drugs for everybody, male or female, young or old, in perpetuity.

Except, of course, for Plan B One-Step since the one thing we know for sure we are not wrong about is that the risk of pregnancy will *always* be greater than the risk of using this drug.